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Active Not RecruitingNCT07077850

Effect of IV Dexamethasone on Post-op Urinary Retention After Spinal Anesthesia

The Effectiveness of Intravenous Dexamethasone Prophylaxis in Preventing Post-operative Urinary Retention in Spinal Anesthesia at Al-Makassed Hospital

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
1,084 (actual)
Sponsor
Al-Quds University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

What is this study about? This study is testing whether a common medication called dexamethasone, given through a vein (IV) before surgery, can help prevent a problem called postoperative urinary retention (POUR). POUR means having trouble urinating after surgery, which can cause discomfort and sometimes requires using a catheter. Who can join the study? The study includes adult People who are having surgery with spinal anesthesia at Al-Makassed Hospital. People who have certain medical conditions, use steroids regularly, or need a catheter during surgery cannot join. What will happen in the study? Participants will be randomly assigned to one of two groups: * One group will get 8 mg of IV dexamethasone before surgery. * The other group will get a saltwater (placebo) injection. Neither the participants nor the doctors will know which treatment they receive. After surgery, the researchers will check how soon each participant can urinate and whether they need a catheter. Why is this study important? POUR can slow recovery and cause complications. Dexamethasone is already used for other reasons like nausea and swelling. This study will help find out if it also lowers the risk of POUR in people getting spinal anesthesia.

Detailed description

Postoperative urinary retention (POUR) is a common complication following spinal anesthesia, affecting patient comfort, recovery, and sometimes requiring catheterization. While dexamethasone is routinely used to prevent nausea and inflammation in surgical patients, its potential role in preventing POUR has not been fully explored, especially in the context of spinal anesthesia. This study is a prospective, randomized, double-blind, placebo-controlled clinical trial conducted at Al-Makassed Hospital. It aims to evaluate whether a single preoperative intravenous dose of 8 mg dexamethasone reduces the incidence of POUR in adult patients undergoing elective surgery under spinal anesthesia. Eligible participants are randomized into two equal groups using block randomization. One group receives 8 mg of IV dexamethasone, and the other receives a placebo (0.9% saline). Both patients and assessors are blinded to group assignment. Data will be collected on age, BMI, comorbidities (including history of BPH or prior POUR), current anticholinergic drug use, anesthetic agent and dose, which level of spinal anesthesia (e.g. L3-L4), type of surgery, IV fluid volume, and duration of operation. The primary outcome is the incidence of POUR, defined as failure to void within 6 hours after surgery and requiring catheterization. Secondary outcomes include time to first void and the overall need for urinary catheterization. Safety data will also be recorded, and any adverse events related to dexamethasone will be reported. The study has been approved by the Al-Quds University Research Ethics Committee. All participants will provide informed consent prior to enrollment.

Conditions

Interventions

TypeNameDescription
DRUGDexamethasone (IV)Intravenous administration of 8 mg dexamethasone sodium phosphate given as a single dose before surgery under spinal anesthesia. This corticosteroid is being evaluated for its potential to prevent postoperative urinary retention (POUR) by reducing inflammation and other perioperative effects.
DRUGNormal Saline (0.9% NaCl)Intravenous administration of 0.9% normal saline (placebo) given as a single dose before surgery under spinal anesthesia. This inert solution is used to compare against the active drug dexamethasone to determine its effect on postoperative urinary retention (POUR).

Timeline

Start date
2025-08-20
Primary completion
2026-08-01
Completion
2026-08-20
First posted
2025-07-22
Last updated
2026-01-12

Locations

1 site across 1 country: Palestinian Territories

Source: ClinicalTrials.gov record NCT07077850. Inclusion in this directory is not an endorsement.